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Diss Factsheets
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EC number: 610-765-8 | CAS number: 52013-44-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Nickel, compound with Titanium (1:1)
- EC Number:
- 610-765-8
- Cas Number:
- 52013-44-2
- Molecular formula:
- NiTi
- IUPAC Name:
- Nickel, compound with Titanium (1:1)
- Details on test material:
- 100% Equiatomic NiTi intermetallic compound
Physical State: free wire
Colour: black
Batch 1048
Expiry Date: not applicable
Constituent 1
Test animals / tissue source
- Species:
- other: bovine corneal
Test system
- Controls:
- other: 3 corneas as positive control treated with ethanol 100%
- Amount / concentration applied:
- The test item was extracted and the test item extract was tested at 100% concentration.
The extraction of the test item was performed according to ISO 10993-12 [8].
In total a ratio of 60 cm2 of sample to 20 mL of extraction medium was used.
The test item was extracted under agitation at 37 ± 1 °C for 72 ± 2 h
The extraction vehicle was physiological saline 0.9% NaCl, B. Braun Melsungen, lot no. 13014404, expiry date: 12/2015
After the extraction procedure neither the test item nor the extraction medium showed any abnormalities. No turbidity, no colour changes and no particles occurred in the extraction medium. - Number of animals or in vitro replicates:
- Test Groups
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive control treated with ethanol 70%
3 corneas as positive control treated with ethanol 100%
The BCOP assay is considered to be valid if the in vitro irritation score obtained with the positive control falls within the two standard deviations of the current historical mean.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- in vitro
- Basis:
- mean
- Score:
- -0.57
- Reversibility:
- not specified
- Remarks on result:
- other: non irritant
Any other information on results incl. tables
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the evaluation criteria the test item Nitinol H/W/1.000/C is classified as non-irritant to eyes.
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